Hepatitis C – Assessment to Treatment Trial (HepCATT) in primary care:study protocol for a cluster randomised controlled trial

Autor: Kirsty Roberts, William L. Irving, Peter Vickerman, Chris Metcalfe, John Macleod, Sharon Marlowe, Fiona H. Gordon, Peter Muir, Joanne Simon, Barbara Coleman, Jeremy Horwood, Matthew Hickman, Cherry-Ann Waldron, William Hollingworth, Graham I. Harrison
Jazyk: angličtina
Rok vydání: 2016
Předmět:
medicine.medical_specialty
Referral
Psychological intervention
Nice
Medicine (miscellaneous)
BTC (Bristol Trials Centre)
law.invention
03 medical and health sciences
Study Protocol
0302 clinical medicine
Randomized controlled trial
Clinical Protocols
Patient Education as Topic
Complex intervention
law
Intervention (counseling)
Health care
Outcome Assessment
Health Care
medicine
Humans
Pharmacology (medical)
030212 general & internal medicine
Cluster randomised controlled trial
Referral and Consultation
HepCATT
computer.programming_language
Primary Health Care
business.industry
030503 health policy & services
Public health
Case-finding
Hepatitis C
Chronic
Primary care
Hepatitis C
Centre for Surgical Research
Family medicine
HCV
Physical therapy
BRTC
0305 other medical science
business
computer
RCT
Zdroj: Roberts, K A, Macleod, J, Metcalfe, C, Simon, J, Horwood, J, Hollingworth, W, Marlowe, S, Gordon, F H, Muir, P, Coleman, B, Vickerman, P, Waldron, C-A, Irving, W L & Hickman, M 2016, ' Hepatitis C – Assessment to Treatment Trial (HepCATT) in primary care : study protocol for a cluster randomised controlled trial ', Trials, vol. 17, 366 . https://doi.org/10.1186/s13063-016-1501-3
Trials
Popis: Background Public Health England (PHE) estimates that there are upwards of 160,000 individuals in England and Wales with chronic hepatitis C virus (HCV) infection, but until now only around 100,000 laboratory diagnoses have been reported to PHE and of these 28,000 have been treated. Targeted case-finding in primary care is estimated to be cost-effective; however, there has been no robust randomised controlled trial evidence available of specific interventions. Therefore, this study aims to develop and conduct a complex intervention within primary care and to evaluate this approach using a cluster randomised controlled trial. Methods/design A total of 46 general practices in South West England will be randomised in a 1:1 ratio to receive either a complex intervention comprising: educational training on HCV for the practice; poster and leaflet display in the practice waiting rooms to raise awareness and encourage opportunistic testing; a HCV risk prediction algorithm based on information on possible risk markers in the electronic patient record run using Audit + software (BMJ Informatica). The audit will then be used to recall and offer patients a HCV test. Control practices will follow usual care. The effectiveness of the intervention will be measured by comparing number and rates of HCV testing, the number and proportion of patients testing positive, onward referral, rates of specialist assessment and treatment in control and intervention practices. Intervention costs and health service utilisation will be recorded to estimate the NHS cost per new HCV diagnosis and new HCV patient initiating treatment. Longer-term cost-effectiveness of the intervention in improving quality-adjusted life years (QALYs) will be extrapolated using a pre-existing dynamic health economic model. Patients’ and health care workers’ experiences and acceptability of the intervention will be explored through semi-structured qualitative interviews. Discussion This trial has the potential to make an important impact on patient care and will provide high-quality evidence to help general practitioners make important decisions on HCV testing and onward referral. If found to be effective and cost-effective the intervention is readily scalable and can be used to support the implementation of NICE recommendations on HCV case-finding. Trial registration ISRCTN61788850. Registered on 24 April 2015; Protocol Version: 2.0, 22 May 2015. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1501-3) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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